An analytical survey of promotional drug literatures at C. U. Shah Medical College and Hospital, Surendranagar.

Background: The research and marketing of a new drug requires a lot of money by the pharmaceutical companies. Promotion through advertising brochures and leafl ets is widely used to infl uence the physicians. Most of the times, this information is the only source of new drug information for the physicians. Hence, this study to analyze the appropriateness, accuracy, and validity of promotional drug literatures was undertaken. Methods: Promotional materials were collected from outpatient departments of C. U. Shah Medical College and Hospital, Surendranagr. They were evaluated according to the “WHO criteria, 1988,” and the references cited to support the claims were checked for their validity and authenticity. The images and the pictorial content were evaluated to fi nd out any biased nature of gender representation. Results: Evaluation of the total 486 brochures showed that none of them fulfi lled all the nine criteria. Of the 308 claims, only 208 (42.79%) gave references to support the claims. Only 27 (39.13%) of the research articles among the 125 journal article cited were of high methodological quality. Among the 218 human fi gures, 144 were patients, and 103 were doctors. Female patients (62.5%) were depicted more than male patients (37.5%). Conclusion: The present study showed that pharmaceutical companies do not strictly follow the WHO guidelines and majority of the research were sponsored by companies. Hence, more stringent regulations need to be implemented for the proper promotion and dissemination of information about the new drugs.

Analytical evaluation of drug package inserts in India.

Background: A drug package insert or prescribing information is a document provided along with a prescription medication to provide additional information about that drug. Drug package inserts are approved by the administrative licensing authority. A package insert is intended to provide information for the safe and effective use of the respective drug. Product information provided by pharmaceutical companies has been determined to be far from adequate and not conforming with requirement of Indian regulatory. Hence, it was decided to conduct a study to assess the presentation and completeness of clinically important information provided in the currently available package inserts in India. Methods: Package inserts were provided by five pharmacies on request. The package inserts were collected in 10 weeks’ period and then they were analyzed for presentation and completeness of clinical information according to heading mentioned in Section 6.2 and 6.3 of schedule D of Drug and Cosmetic Rule, 1945. If the information was present under relevant heading, it was scored as one. Otherwise as score of zero was assigned. Total score for each heading was calculated by adding the score from the individual package inserts. Results: 70 package inserts were included in the study. None of the reviewed package inserts contained all the sections as required by the Drugs and Cosmetics Act. Total 15 headings were evaluated under both Section 6.2 and 6.3, highest value for the presence of heading were 12 out of 15 heading evaluated. That shows the best value of compliance was 80%. Conclusion: Accurate drug product information is important for the safe and effective use of medicines. Hence, pharmaceutical companies and regulators should ensure that accurate and up to date product information is provided in the package inserts.

To study cost effectiveness of topical permethrin versus oral ivermectin in patients of uncomplicated scabies.

Background: The objective of this study was to compare the cost and effectiveness of topical permethrin and oral ivermectin in the treatment of uncomplicated scabies. Methods: This was an open label randomized comparative study conducted in 210 patients, randomly allocated to two groups. First group received permethrin 5% cream as single application, second group received tablet ivermectin 200mcg/kg as single dose. All the patients received antihistaminic for pruritus. The patients were followed up at intervals of one, two, three and four weeks. If there were no signs of cure, the same intervention was repeated at each follow up. The cost effectiveness was calculated on the basis of total expenditure incurred on therapy. Results: At the end of first week cure rate was 74.8% in permethrin group, 30% in oral ivermectin group. At the end of second week cure rate was 99% in permethrin group, 60% in oral ivermectin group. At the end of third week 100% cure rate was observed in permethrin while 99% in oral ivermectin group. The total cost of treatment shows that cost of tab. ivermectin was less compared to permethrin 5% but the cost to relieve itching and cost of transport was higher than permethrin 5%. Conclusions: Topical permethrin is more cost effective than oral ivermectin in treatment of uncomplicated scabies.

Prevalence of G6PD deficiency versus oxidizing drugs: a survey in the tertiary care hospital.

Background: G6PD deficiency is distributed worldwide including India and is involved in accidental hemolysis and anemia by inadvertent use of oxidizing drugs. Awareness of community wise occurrence of G6PD deficiency can help in screening beforehand. Methods: On 150 community wise classified, non-anemic, non- hemolysed (in recent past) visitors of pathological laboratory attached to C U Shah Medical College, Surendranagar, Gujarat, Crayman’s hemoglobin colorimetric kit (item no 700540) was used to estimate normal or below normal status of G6PD. Results: 10 people (6.6% of population) were found deficient – 7 (4 male + 3 female) from Harijan community, 2 (1 male + 1 female) from Rabbari community and 1 (1 male + 0 female) from Lohana community. Conclusions: While applying oxidizing drugs in a person of Harijan community (prevalence 7 out of total 26, i.e. 27%), extra caution is required, esp. if a person otherwise vulnerable (e.g. alcoholic). For other less represented communities, larger stratified sampling is required.

Ivermectin: pharmacology and therapeutic applications.

Ivermectin is an antiparasitic drug with a broad spectrum of activity, high efficacy as well as a wide margin of safety. It belongs to the family of avermectins. It binds to glutamate-gated chloride iron channels, which are present in invertebrate nerve and muscle cells, and causes the paralysis and death of the parasite. Ivermectin is approved by the US Food and Drug Administration, and used worldwide to treat patients with onchocerciasis and strongyloidiasis. It is also used against a wide range of endoparasites (nematodes) and ectoparasites (insects, acarine) of animals and humans.

Comparative efficacy and safety of topical permethrin, topical ivermectin, and oral ivermectin in patients of uncomplicated scabies.

Background: Ivermectin has opened a new era in the management of scabies as orally effective drug. However, topical route has been little explored for ivermectin. Aims: To compare the efficacy and safety of topical permethrin, oral ivermectin, and topical ivermectin in the treatment of uncomplicated scabies. Methods: This was an open-label, randomized, comparative, parallel clinical trial conducted in 315 patients, randomly allocated to 3 groups. First group received permethrin 5% cream as single application, second group received tablet ivermectin 200 mcg/kg as single dose, and third group received ivermectin 1% lotion as single application. All the patients received anti-histaminic for pruritus. The patients were followed up at intervals of 1, 2, 3, and 4 weeks. If there were no signs of cure, the same intervention was repeated at each follow up. Primary efficacy variable was clinical cure of lesions. Statistical analysis was done by chi square test and one way ANOVA test using SPSS version 12. Results: At the end of first week, cure rate was 74.8% in permethrin group, 30% in oral ivermectin group, and 69.3% in topical ivermectin group (P < 0.05). At the end of second week, cure rate was 99% in permethrin group, 63% in oral ivermectin group, and 100% in topical ivermectin group (P < 0.05). At the end of third week, 100% cure rate was observed in permethrin and topical ivermectin group while 99% in oral ivermectin group (P = 0.367). No serious adverse events were observed. Conclusions: Permethrin and topical ivermectin were equally effective against scabies while oral ivermectin was significantly less effective up to 2 weeks. Topical ivermectin can be used as an alternative to permethrin.

Wound healing and anti-inflammatory activity of extract of Ficus racemosa linn. bark in albino rats.

Background: F. racemosa is an indigenous plant having anti-secretory, anti-diabetic, anti-ulcer etc. properties. It is used widely in the ayurvedic medicines. Methods: The experimental models of wound and inflammation were used to assess the wound healing and anti-inflammatory properties of F. racemosa. The significance of differences was analyzed using students’ ‘t’ test. Results: In the strength of 10% local application it could apparently enhanced the process of healing. At the dose of 20 mg/100 gm intraperitoneally it could show inhibition of carageenan induced acute inflammation at 3rd, 5th and 7th hour and at the dose of 30 mg/100 gm intraperitoneally, formalin induced subacute inflammation was inhibited till 4th day. The results were found statistically significant. Conclusions: Aqueous extract of F. racemosa has got wound healing and anti-inflammatory activity. It is likely that the duration of action may be shorter.

Approval of antineoplastic agents in India: comparison with the US and EU regions.

Background: The antineoplastic drugs are prescribed for the treatment of cancer, which is an important cause of mortality in India; therefore, a drug lag in the availability of antineoplastic drugs is a direct threat to life. The present study was undertaken to assess the drug lag for new antineoplastic agents in India compared with that in the United States (US) or European Union (EU). Methods: The new antineoplastic agents approved in the United States, European Union and India between 1999 and 2011 were identified and information was gathered primarily from the websites of regulatory agencies of the three regions. We assessed absolute and relative drug lag for new antineoplastic agents approved in the three regions. Results: Of the 70 new antineoplastic agents, 64 (91.42%) were approved in the United States, 54 (77.14%) in the European Union and 44 (62.85%) in India. The US was the first to approve 59 (84.28%) out of the 70 new antineoplastic agents, the EU was the first to approve 9 (12.85%) and India was the first to approve 2 (2.85%). The median approval lag for India (26.35 months) was higher as compared to the United States (0 month) and European Union (7.3 months). Conclusions: This study confirms that India’s drug lag in the case of new antineoplastic agents is higher as compared to the US and EU. Further detailed analyses are necessary to find the reasons and impacts of drug lag for antineoplastic agents in India.